ANZCTR search results

Cognitive decline is the primary symptom of dementia and is preceded by reduced brain blood vessel (i.e. cerebrovascular) function. Cognitive decline and cerebrovascular dysfunction are made worse by obesity, which results from a poor diet and low physical activity levels. These are increasingly prevalent in regional Australia and contribute to the increase in dementia rates, reducing quality of life of older Australians. Current preventive treatments for dementia focus on reducing risk factors, including exercise and diet, but these are associated with low compliance. Capsaicin, the spicey molecule in chilli, reduces fat mass and blood pressure in humans. It also improves markers of cardiovascular disease and cognitive decline in animal models of disease by reducing inflammation and improving blood vessel function. However, capsaicin can cause oral and gastrointestinal irritation, limiting its potential for human use. Capsimax is a unique beadlet encapsulation of capsaicin that prolongs capsaicin release in the gut, and prevents irritation associated with capsaicin ingestion. Hence, Capsimax is a safe and tolerable supplement that can be used to examine the effects of capsaicin in humans. We will conduct a randomised control trial that will investigate the effects of Capsimax supplementation for 12 weeks on cognition and cerebrovascular function in middle-aged to older, overweight and obese adults who are at risk of cognitive decline and dementia. This pilot study will be the first human study to explore the use of a capsaicin supplement in improving cognition and cerebrovascular function, thus providing a foundation for future use as a preventive treatment for dementia.

RECALL-Pilot is a prospective, decentralised pilot trial to investigate the feasibility of using a blood pressure lowering ‘polypill’ including telmisartan 20mg, amlodipine 2.5mg, indapamide 1.25mg in a decentralised trial to prevent ‘significant cognitive impairment’ (MCI or dementia).

Telehealth is an emerging way of assessing and managing patients, particularly after the COVID-19 pandemic. The role of telehealth in concussion diagnosis and management is not fully researched yet, therefore in this trial, we are in the first instance testing the effectiveness of the diagnostic ability of a telehealth program. This trial is running for 2 years and is available to all players in VAFA and will enrol at least 500 head-injured patients with suspected concussion. If deemed eligible, participants will be randomly allocated to either one of the following two treatment options: a) attending an online virtual video-based telehealth consultation with a neuropsychologist/ neurologist or physiotherapist which will take about 45 minutes OR b) provided with the most current and available concussion/head injury advice. There will be no restrictions on participants in terms of lifestyle or regular medications or behaviours. Regardless of which option participants are randomised to, they will be contacted on day 7 and day 14 post head injury regarding their clinical symptoms. If they attend the telehealth consultation, they will also be contacted again on day 30 to assess their satisfaction and feedback regarding the telehealth program. The primary outcome for this study is the diagnosis rate, whilst secondary outcomes include symptom improvements, RTP adherence, access to clinical specialists, and user satisfaction with the telehealth program.

The purpose of this study is to investigate whether we can use co-mutation NGS profiling (looks for gene changes in your cancer tissue) and circulating tumour (ct) DNA (looks for fragments of the tumour moving through the blood stream. These fragments are known as circulating tumour DNA (ctDNA) and carry genetic information) to determine which patients with EGFR mutant non small-cell lung cancer can safely avoid chemotherapy. Who is it for? You may be eligible for this study if you are an adult with non small-cell lung cancer, with a mutation in epidermal growth factor receptor (referred to as EGFR mutation) that has had their tumour completely resected by surgery. Study details: During screening NGS profiling and ctDNA testing will be performed. The NGS and ctDNA results will be used to determine if your cancer is at higher or lower risk of returning. Participants with a higher risk of their cancer returning will have up to 4 cycles (over 12 weeks) of chemotherapy followed by up to 3 years of daily osimertinib. Participants with a lower risk of their cancer returning will have osimertinib daily for up to 3 years. The following assessments will be conducted throughout the trial: physical exam, CT scans, MRI, blood tests, pregnancy test, ECG and questionnaires. It is hoped that this study will help determine if osimertinib alone may provide similar benefits with less toxicity, improved quality of life and reduced health care costs, to chemotherapy and osimertinib.

LeapForward is a digitised 6-week clinician supported program harnessing psycho-education, technology and coaching to support people in a return to health, life and work after (compensable) injury or illness. LeapForward aims to address the psychosocial barriers that can most significantly impact recovery – by empowering individuals with the will-and-skill to move forward in their recovery with confidence-and-control. Whilst LeapForward has been developed based on leading evidence-based principles, a rigorous evaluation is required to determine the program’s ability to engage and retain users, to induce change in users’ health and wellbeing, and ultimately – to causatively impact on (personal injury) claim costs on a macro-scale within an MVA-scheme environment, through impacting weekly benefits and/ or total treatment costs. IAG and NRMA are evaluating whether providing their customers with a web-based health program called LeapForward can help claimants as part of their recovery after a motor vehicle accident. We aim to conduct an independent evaluation of this program.

Across NSW and Victoria, 860,000 children, 30% of the States’ population, live in rural areas. Although 19% of these children live with a chronic illness, there are fewer GPs per capita and paediatric specialty care is often lacking. Strengthening Care for Rural Children (SC4RC), a model where paediatrician and GP’s work together in GP practices, aims to deliver and rigorously evaluate a primary health care system strengthening programme that can bridge the gaps in access to health services and health outcomes between children living in rural Australia and their urban peers. It aims to improve the health of children by increasing the capacity of the existing rural GP workforce to assess and effectively manage paediatric conditions.

The SWAP IT program is integrated within an app-based communication platform used by schools to communicate with parents and consists of text-messages sent to parents targeting barriers to packing healthier lunchboxes. SWAP IT has proven to be effective in improving child nutrition and weight outcomes, is acceptable to parents and principals, and is cost effective (Sutherland 2019, Sutherland 2021 (ACTRN12618001731280)). Although SWAP IT has the potential to improve child health at a population-level, little evidence exists to guide efforts to encourage school adoption of these programs at scale. This research aims to maximise the impact of the SWAP IT program through a scale-up involving 450 primary schools across three states (VIC, QLD, SA). A randomised trial will be undertaken with schools allocated to receive either a 9-month multi-component scale-up strategy or to a control group. The scale-up strategy is theory-based and was developed in consultation with researchers and stakeholders from health, education and industry. Key outcome measures include: a) SWAP IT program adoption; b) Population level impacts on child nutrition and obesity; c) Sustainment; d) Economic evaluation; and e) Mechanisms of action. This research will result in new knowledge to inform how school-based nutrition programs can be successfully scaled-up at a population level.

Patients with orthopaedic implant or trauma related infection are a complex population. Many live out of the Metro North Health catchment with no local access to the expertise required for their complex needs. The multi-disciplinary Device Related Infection Team (mDRIFT) commenced in 2020 by Jamieson Trauma Institute at Royal Brisbane and Womens Hospital to help combat this difficult clinical complication through effective coordination of patient care. This study will provide a dynamic communication pathway utilising a low-cost app framework as a new way to facilitate two-way communication between clinicians and patients. This project will implement and evaluate an innovative digital platform for patient-doctor communications which are personalised and aligned with each patient’s health journey. It will be tested by patients who have been diagnosed with orthopaedic implant or trauma related infections and are being treated at RBWH. Our goal is to expand its use to other complex conditions which require ongoing multidisciplinary care. The new platform has the potential to improve communication between patients and the clinical team. The platform will also include: 1. Sensor-generated data (heart rate, activity, sleep) from a consumer-grade wearable tracking device, to improve remote monitoring and assessment of the patient’s recovery 2. Gamification, an innovative approach to behaviour change, with a reward system. This aims to provide motivation to patients and their families and increase engagement and adherence to treatment plans. The expected outcomes of this integrated approach will be improved patient outcomes and reduced costs of care for regional and remote patients.

The primary aim of the study is to test and compare the two approaches of remote monitoring: Source data verification via uploading of documents and source data verification via live monitoring through a platform such as zoom. Based on the trial risk categorisation of BALANCE trial ( NCT 03005145) Australian national guidelines support the use of remote monitoring for this type of trial. The term remote monitoring describes monitoring activities that were previously conducted at the trial site by the trial monitor, but can now be conducted off-site (e.g., the review of documents sent by e-mail) (NHMRC guidelines on Risk-based management and monitoring of Clinical Trials involving therapeutic goods, 2018’) A key component of the monitoring is Source Data Verification (SDV), where the primary document is reviewed by a monitor for completeness and accuracy. There are three key approaches used for SDV. a) ‘Document up-load’ SDV where a site share requested documents through fax, email, upload into cloud-based file share system for review by the monitor at a later time b) ‘Live video’ SDV where the study monitor reviews and confirms source data in real-time over a video-link with the study site, c.) sites may facilitate a monitor’s direct access to their electronic medical record (EMR) allowing the monitor to directly locate and review source data. There isn’t sufficient literature to suggest the benefits of different remote monitoring approaches and also when and if one method should be preferred over the other. In this study, we aim to compare the two most commonly used approaches to SDV (document up-load and live video) and evaluate the effectiveness of both approaches.

This study primarily aims to evaluate whether a novel online CBT program for fears of death significantly reduces death anxiety amongst individuals with an anxiety-related disorder, compared to a waitlist control group. Given participants in the pilot study demonstrated clinically reliable reductions in death anxiety and other clinical measures after completing the program, we expect a statistically significant reduction in death anxiety amongst individuals with an anxiety disorder compared to the waitlist control will be observed. The study will also explore whether any improvements in death anxiety are associated with improvements in broad mental health. Furthermore, this study also seeks to obtain qualitative and quantitative feedback on the program, to guide further development. This will be critical to improve the program for future phases of the clinical trial. Given prior user evaluations of online interventions with a similar structure and design to the current program (Helgadottir et al., 2009; Menzies et al., 2023), it is hypothesised that the present intervention will be perceived as user-friendly, clear, acceptable, and efficient.